Industrial microbiology is a critical function in the biopharmaceutical sector as its purpose is to monitor for contamination events and inform development of standard operating procedures to minimize the risk of contamination. As increasing levels of automation and digitalization are incorporated into industrial microbiology workflows, the result will be process improvement, greater process control, improved traceability, and cost reduction – coming from reduced manual steps and from optimizing personnel, equipment, and material workflows.
One of the most important benefits of automated, digitalized processes is in ensuring data integrity, which is a focus of the biopharmaceutical industry and regulatory authorities, including the FDA and EMA. Data integrity means that the data, the results of analyses, and the way analyses are conducted, cannot be manipulated. Importantly, it must also be proven that data has not been altered.
Relying on automation and digitalization is a new proof of trust for regulatory authorities. At a very high level, the goal is to ensure product safety, verify process performance, increase batch success rates, and enable faster batch release and patient access – all while reducing manual errors, interventions, and variability. A full end-to-end chain, provided by a superior system, offers assurance that there is no alteration of data throughout the process, and further proves the quality of the resulting product to assure patient safety.
Users, and regulators alike, need assurance that data are correct and repeatable. Results must be validated and have been well-documented throughout the process. Users must be also be able to monitor whatever has been coming into or leaving the process and have access to the full record of how the product is being made, and proof that it remains within the acceptable norms for the final product. Going a step further, the ability to detect a potential problem and trace it to its source can enable it to be addressed before it becomes a bigger problem – thereby ensuring the quality and consistency of the product and increasing process efficiency. From there, adding automation for performing routine tasks can further reduce the risk of variability from one day to the next and from one operator to another.
Automation and digitalization enable traceability of all ingredients on the production line and can provide a complete record of how the product is being made, and that it is within the acceptable range for the final product. This reduces risk from a predictability standpoint.
To get started on the automation and digitalization journey, a company should take a holistic view of the entire workflow, understand the project goals, and then consider how automation and digitalization could be applied to enhance workflow performance.
Patience and good partners will be needed. Automation projects are a significant undertaking and require absolute clarity as around the project’s objective and the problems that need to be solved. These projects are a significant investment in terms of people and financial resources and require strong ownership and sponsorship from senior management since these projects deeply integrate into the way the lab and the organization operate. Automation and digitalization can represent a substantial change in the way employees operate on a daily basis and as such, it is essential to have robust change management processes in place.
No doubt, automated and digitalized technologies will have a profound impact on industrial microbiology. From improved data integrity to process improvement, greater process control and reductions in variability and errors – the benefits will be significant. Automation and digitalization also provide more flexibility in terms of remotely verifying process performance and results and can help to make the shift towards continuous, in-line testing.
We believe it is incumbent upon suppliers and manufacturers, like our organization, to help drive change and engage with customers on an entirely new level. As innovative technologies such as the Internet of Things, cloud computing, big data, and artificial intelligence become more embedded in our workplaces, the discussion must now evolve to include the information technology (IT) function in more proactive manner, starting by understanding how data is shared and where it resides. Does it sit in a cloud? Where does that cloud sit? The discussion not only needs to focus on products used in the lab, and how they can make processes more efficient and reliable, but also include IT and a data risk management perspective. The conversation must encompass IT and engineering, in addition to a strong foundational understanding of the objectives, workflows and data intersections required to move towards the vision of Industry 4.0 and pave the way for a better, automated, and digitalized approach to industrial microbiology.